Intralumenally-implantable frames

ABSTRACT

Implantable frames for use in body passages are provided herein. The implantable frames can include a plurality of hoop members joined by a plurality of longitudinal connecting members to form a tubular frame defining a cylindrical lumen. The plurality of longitudinal connecting members may include first and second longitudinal connecting members joining a first hoop member to a second hoop member such that the first and second longitudinal connecting members extend across an entire space separating the first and second hoop members.

RELATED APPLICATIONS

This application is a continuation of co-pending U.S. patent applicationSer. No. 11/545,746, filed on Oct. 10, 2006, which claims the benefit ofU.S. provisional patent application 60/725,678, filed Oct. 12, 2005; andwhich is a continuation-in-part of co-pending U.S. patent applicationSer. No. 10/828,716, filed Aug. 30, 2004 and entitled, “Artificial ValveProsthesis with Improved Flow Dynamics,” by Case et al., which in turnclaims priority to U.S. Provisional Applications 60/465,141 filed Apr.24, 2003 and 60/530,781, filed Dec. 18, 2003; and which is also acontinuation-in-part of U.S. patent application Ser. No. 11/487,629,filed Jul. 17, 2006, which in turn claims the benefit of U.S.Provisional Patent Application 60/700,852, filed Jul. 19, 2005. Each ofthese related applications is incorporated into this disclosure in itsentirety.

TECHNICAL FIELD

The present invention relates generally to the field ofintralumenally-implantable medical device frames for placement in a bodypassage and related methods of treatment. The implantable frames can beused as stents, or form portions of valves or stent grafts.

BACKGROUND

Intralumenally implantable frames can be implanted to treat a variety ofmedical conditions. Implantable frames can maintain patency of bodyvessels or provide support for a valve or valve leaflets for regulatingfluid flow within a body lumen. For example, flexible leaflet materialcan be attached to an implantable frame to form a valve prosthesisuseful in providing an artificial valve for treating venous valveinsufficiency. In addition, a variety of other implantable prostheses,such as stents, stent grafts and the like, comprise a radiallyexpandable support frame placed within the body to improve the functionof a body lumen. Support frames may be implanted in vessels, ducts orchannels of the human body and can form part of a valve to regulatefluid flow within a body lumen or as scaffolding to maintain the patencyof a body vessel, duct or channel to treat various conditions.

Endolumenal prostheses comprising support frames can be placed in a bodylumen from a delivery system which includes a catheter. Implantableframes can be intralumenally delivered inside the body by a catheterthat supports the stent in a radially compressed form as it istransported to a desired site in a body vessel. Upon reaching the site,the implantable frame can be radially expanded and securably positionedwithin the lumen of the body vessel, for example by engaging the wallsof the body vessel with a portion of the implantable frame. Theexpansion mechanism may involve expanding the implantable frame radiallyoutward, for example by inflation of a balloon carried by the catheter.Alternatively, when the implantable frame is formed of a self-expandingmaterial, the implantable frame may be delivered in a radiallyrestrained configuration and deployed by removing the restraint at apoint of treatment to allow the implantable frame to self-expand by itsown internal elastic restoring force at a point of treatment. Afterexpansion of the implantable frame, the catheter delivery system issubsequently withdrawn from the body vessel. Endolumenally implantablesupport frames preferably possess sufficient hoop strength to resistcollapse of the body vessel, while maintaining a desired degree ofradial or longitudinal flexibility to prevent damage to the body vessel.

Implantable frames are subjected to various mechanical forces before,during and after deployment within a body lumen. Before deployment,implantable frames can be compressed and maintained in a compacted form,which can include subjecting the implantable frame to a prolonged inwardradial restraining force. During deployment, implantable frames can besubjected to an outward radial expanding force, for example from aballoon expansion or self-expansion process. The implantable frames canalso be subjected to an inward radial compressive force upon contactwith the body vessel wall during deployment expansion. After deployment,implanted frames can be subject to continued inward radial force fromthe body vessel wall, in addition to a variety of shearing or tortionalforces imparted by movement of the body vessel wall or fluid flow withinthe body vessel. Uneven mechanical load bearing within an implantableframe can result in uneven wear and distortion of the implantable frameshape, or even failure of structural integrity. In typical sinusoidaland near sinusoidal designs, the bends or radial arcs experience areasof high strain and stress, which can lead to areas of frame fatigue orfracture. However, the stress and/or strain experienced along the lengthof the radial arc may not be uniform, and there are areas of relativelyhigh stress and/or strain. Therefore, it is desirable to provideimplantable frames that more evenly distribute mechanical loads.

Dynamic fluctuations in the shape of the lumen of a body vessel, such asa vein, pose challenges to the design of support frames for implantationwithin the body vessel. For instance, the flow velocity and diameter ofveins do not remain essentially constant at a given systemic vascularresistance. Instead, the shape of vein lumens can fluctuate dynamicallyin response to the respiration, body position, central venous pressure,arterial inflow and calf muscle pump action of a mammalian subject. Theveins also provide the principal volume capacitance organ. For example,an increase of almost 100% in the diameter of the common femoral veinhas been observed in human patients simply by rotation of the patient byabout 40 degrees, corresponding to a four-fold increase in blood flowvolume. Moneta et al., “Duplex ultrasound assessment of venousdiameters, peak velocities and flow patterns,” J. Vasc. Surg. 8; 286-291(1988). The shape of a lumen of a vein can undergo dramatic dynamicchange as a result of varying blood flow velocities and volumestherethrough, presenting challenges for designing implantableintralumenal prosthetic devices that are compliant to the changing shapeof the vein lumen.

Preferably, implantable frames are also configured to minimizeundesirable irritation of the lining of a body vessel upon implantation,for example by minimizing the surface area of the frame in contact withthe body vessel. However, reducing the surface area of the frame mayincrease the mechanical stress and strain on particular portions of theframe, particularly bends or arcuate sections. What is needed areendolumenally implantable medical device frames configured to withstandradial compression upon implantation by desirably distributing theassociated mechanical strain on the implanted frame, while alsominimizing potential irritation of a body vessel that may result fromcontact between the body vessel and the external surface of theimplanted frame.

SUMMARY

Intralumenally implantable frame configurations adapted for placementwithin a body passage are provided herein. The present disclosureprovides implantable frames configured to balance often competingconcerns of minimizing potentially irritating external surface area,minimizing foreshortening during radial expansion, and providing adesirable distribution of mechanical loading within the frame duringmovement of the frame within a dynamic body vessel such as a vein. Theseimplantable frames are particularly useful, for example, as a supportfor a valve for correcting fluid flow within a body passage, or foropening, dilating and maintaining body vessels and other biologicalducts which are at risk of closure or constriction. For example, theimplantable frames may be configured as stents for maintaining thepatency of a body vessel or as support frames for valves or stentgrafts.

The implantable frames preferably have a substantially tubularconfiguration and include two or more hoop members axially alignedaround a longitudinal axis and joined by a plurality of longitudinalconnecting members. The hoop members and the longitudinal connectingmembers define a plurality of open spaces in the exterior surface of thetubular frame. The longitudinal connecting members are preferablyarranged in a configuration suitable to provide an implantable framewith a desired radial compression upon implantation while favorablydistributing the mechanical strain imparted to the implanted frame dueto post-implantation radial compression of the body vessel at the siteof implantation. The implantable frames may be configured to minimizepotential irritation of a body vessel that may result from contactbetween the body vessel and the external surface of the implanted frame,for example by minimizing the surface area and number of hoop membersand longitudinal connecting members. The implantable frame is preferablyadapted for transluminal percutaneous delivery in a radially compressedstate from a delivery system comprising a catheter. The frame ispreferably moveable between a radially compressed state and a radiallyexpanded state by any suitable means within a body vessel, includingballoon expansion or self-expansion from a delivery catheter positionedwithin a body vessel.

Preferably, the implantable frame comprises a plurality of longitudinalconnecting members connecting a pair of hoop members to form a tubularframe defining a cylindrical lumen. The plurality of longitudinalconnecting members desirably includes one or more pairs ofclosely-spaced longitudinal connecting members oriented substantiallyparallel to the longitudinal axis of the tubular implantable frame.Preferably, a tubular implantable frame includes two or more hoopmembers axially aligned around a longitudinal axis of the frame. Thelongitudinal connecting members are preferably substantially straightstruts aligned substantially parallel to the longitudinal axis of theimplantable frame. In one aspect, the longitudinal connecting membersare substantially equal in length.

Longitudinally adjacent hoop members are desirably connected by anysuitable number (n) of longitudinal connecting members, where (n) ispreferably an integer equal to 2-16, and more preferably 4-8.Preferably, the circumferential distance between longitudinal membersvaries as a function of the number of longitudinal connecting members,with at least two of the longitudinal connecting members beingclosely-spaced. Closely-spaced longitudinal connecting members arecircumferentially adjacent members that are circumferentially closer toone another than to the next nearest circumferentially adjacentlongitudinal connecting member. The circumferential distance betweenlongitudinal connecting members is measured along the outer surface of atransverse cross section of the frame, where the cross section iscentered on, and oriented perpendicular to, the longitudinal axis. Forexample, in a frame having a second longitudinal connecting membercircumferentially adjacent to both a first longitudinal connectingmember (in a first circumferential direction) and a third longitudinalconnecting member (in a circumferential direction opposite the firstcircumferential direction), the circumferential distance measuredbetween the first longitudinal connecting member and the secondlongitudinal connecting member that is closely spaced with respect tothe first longitudinal connecting member is less than thecircumferential distance measured from the first longitudinal connectingmember to a third longitudinal connecting member that is notclosely-spaced with respect to the first longitudinal connecting member.In one aspect, the angle subtended by a hypothetical arc extendingcircumferentially along the perimeter of a cross section of a frame froma first longitudinal connecting member to a second longitudinalconnecting member that is closely-spaced with respect to the firstlongitudinal connecting member is less than (2.pi./n) radians, where (n)is an integer equal to the number of longitudinal connecting membersbetween longitudinally adjacent hoop members. In a second aspect, theshortest circumferential distance between the closely pairedlongitudinal connecting members can be less than about 25%, preferablyless than about 15%, of the length of the closely spaced pair oflongitudinal connecting members. The frame desirably includes two ormore pairs of closely spaced longitudinal connecting memberssymmetrically positioned across a tubular frame lumen from another pairof closely spaced longitudinal connecting members.

The hoop members can have any suitable configuration. For example,undulating hoop members typically include a plurality of alternatingstruts and bends forming a sinusoidal pattern defining a portion of theexternal surface of a tubular frame. Alternatively, the hoop members canbe planar rings formed from a single bent member. Optionally, the frameincludes one or more undulating hoop members formed from a plurality ofinterconnected struts and bends oriented along the longitudinal axis ofthe frame. For example, a frame can include a first undulating hoopmember having a total of (m) struts joined to a total of (2 m)longitudinal connecting members, wherein (m) is preferably an integerequal to 2-16, preferably 2-8. The frame can further comprise aplurality of lateral support arms connecting facing pairs of adjacentstruts within the hoop members positioned at the ends of the frame. Alateral support arm preferably comprises a single bend connecting a pairof lateral support struts. The hoop members preferably havesubstantially similar configurations, although frames may include hoopmembers with different configurations. The cross section of each hoopmember desirably forms a perimeter around a substantially circular orelliptical lumen. Each hoop member can optionally include an undulatingpattern of struts and bends extending along the axis of the frame.Preferably, the ratio of bends to struts in an undulating hoop member is1:1 to 3:1, more preferably 2:1 to 3:1, with the struts having asubstantially equal length within each hoop member. Alternatively, oneor more hoop members can have a planar geometry, such as a single bentmember forming an annular shape. The plurality of hoop members can havethe same or different configurations, but are preferably concentricallyaligned along the longitudinal axis of the frame. Each of the bends inthe hoop members are preferably connected to a longitudinally adjacenthoop member by at least one longitudinal connecting member.

While the invention is defined by the claims appended hereto, additionalunderstanding of the invention can be gained by reference to theattached drawings and the description of preferred embodiments presentedbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying drawings:

FIG. 1A is an unrolled flat plan view of a first implantable frame.

FIG. 1B is a perspective view of the first implantable frame of FIG. 1Ashown in the radially expanded configuration.

FIG. 1C is a side view of the first implantable frame in the radiallycompressed state shown in FIG. 1B.

FIG. 2A is a perspective view of the first implantable frame of FIG. 1Ashown in the radially expanded configuration, showing a cross sectionalplane.

FIG. 2B is a cross sectional view of the expanded first implantableframe of FIG. 1A within the cross sectional plane shown in FIG. 2A.

FIG. 3A is a side view of a second implantable frame in the expandedconfiguration.

FIG. 3B is a side view of a third implantable frame in the expandedconfiguration.

FIG. 4A is an unrolled flat plan view of a fourth implantable frame.

FIG. 4B is an unrolled flat plan view of a fifth implantable frame.

FIG. 5 is a side view of a sixth implantable frame of shown in theradially expanded configuration.

FIG. 6 is a schematic view of a delivery system showing portions of adelivery catheter and an implantable frame expanding from the compressedstate to the expanded state.

DETAILED DESCRIPTION

Although the following discussion, along with the figures, describesillustrative embodiments, those skilled in the art will understand thatvariations and combinations of the described embodiments are alsodisclosed herein.

The terms “implantable frame” and “frame” are used interchangeably torefer to the structures disclosed herein to one of skill in the art.Preferably, the frames are configured for implantation within a bodyvessel.

The terms “proximal” and “distal” are used to connote a direction orposition relative to each other. Unless otherwise indicated, therecitation of “proximal” or “distal” portions of a frame does not referto any particular orientation of the implantable frame within a body.The implantable frames described herein can be used in many differentbody lumens, including both the arterial and venous system, and can beimplanted in any suitable orientation within the body.

A frame “perimetrically defining” an opening means that substantiallythe entire perimeter of the opening is defined by portions of the frame.A frame opening “bounded” by a specified portion of the frame means thatat least part of the perimeter of the opening is defined by thespecified portion of the frame. For example, an implantable frame cancomprise an opening between a substantially cylindrical exterior surfaceand a substantially cylindrical interior lumen that are bounded by aspecified portion of the implantable frame may also be perimetricallydefined by a combination of the specified portion of the implantableframe and other portions of the implantable frame.

The term “circumferential” or “circumferentially” refers to a directionor displacement measured along the exterior surface area of an assembledimplantable frame in the expanded configuration that is transverse tothe longitudinal axis of the implantable frame. The recitation of afirst structural feature “circumferentially adjacent” to a secondstructural feature means that the first structural feature is thenearest first structural feature to the second structural feature whenmoving circumferentially along the exterior surface of an implantableframe. The term “circumferential distance” means distance measured alongthe exterior surface of an implantable frame in the expandedconfiguration.

The term “longitudinal” or “longitudinally” refers to a directionmeasured along the longitudinal axis of the implantable frame. The term“longitudinally opposite” means positioned in a distal or proximaldirection along the exterior surface of an implantable frame parallel tothe longitudinal axis of the implantable frame. The recitation of afirst structural feature “longitudinally adjacent” to a secondstructural feature means that the first structural feature is thenearest first structural feature to the second structural feature whenmoving longitudinally along the exterior surface of an implantableframe. The term “longitudinal distance” means a distance or displacementmeasured parallel to the longitudinal axis of an implantable frame inthe expanded configuration, measured along the exterior surface area ofthe implantable frame.

The term “arcuate” refers to a curved structure or portion thereof.

The term “semi-circular” refers to an arcuate structure forming aportion of a circle.

The term “symmetrically positioned” refers to a similarity in size,shape, or relative position of corresponding parts.

The term “superelasticity” is used herein to describe the property ofcertain shape memory alloys to return to their original shape uponunloading after a substantial deformation while in their austeniticstate. Superelastic alloys can be readily strained while in theiraustenitic state with minimal plastic deformation. Alloys that showsuperelasticity may also undergo a thermoelastic martensitictransformation.

As used herein, the term “strut” refers to a substantially straightportion of a frame, while the term “bend” refers to an arcuate portionof the frame.

As used herein, the terms “peak” and “valley” are used interchangeablyto refer to bends in portions of a frame.

The term “symmetrically positioned” refers to a similarity in size,shape, or relative position of corresponding parts.

Typically, implantable frames are subjected to periodic and repeatedradial compression and expansion upon implantation. For example, framesimplanted in the vascular system are subject to radial movementresulting from periodic blood flow, and accompanying changes in fluidflow rate and pressure due to the approximately 8 million heart beats ofa human patient every year. Frames in veins may undergo radialcompression as veins dilate or prolapse in response to changes in bodyactivity or position, in addition to pulsatile blood flow. The stressand/or strain experienced along the length of an implantable frameduring radial compression or expansion is typically not uniform, andthere are areas of relatively low stress and/or strain. Implantableframes comprising sinusoidal hoop members, the radial arcs oftenexperience areas of high mechanical strain and stress during radialcompression and expansion, which can lead to fatigue and even failure(e.g., fracture of the frame). One method of predicting the stressand/or strain state in the structure is finite element analysis (FEA),which utilizes finite elements (discrete locations). “Finite elementanalysis” is a mathematical approach wherein a frame structure issegmented into many pieces that have closed form solutions. That is,each piece can be defined by a linear equation, and hence is a “finiteelement.” Collectively, the linear equations of the pieces form a systemof equations that are simultaneously solvable. Computer programs forsimulating finite element analysis in various applications exist. Forexample, design engineers use finite modeling programs. Typically, manythousands of elements are created to model a subject object and inparticular three-dimensional objects. For each element, there isgeometric information such as an x-y-z coordinate at a point in theelement, an element type, material property, stress value, displacement,thermal value, etc. Such information is definable by linear equationsfor the elements. To that end, finite analysis is employed to model thesubject object. Examples of finite modeling programs include: ABAQUS byHibbitt, Karlsson, and Sorensen, Inc. of Pawtucket, R.I., ANSYS bySwanson Analysis Systems Inc. of Houston, Pa.: SUPERTAB by StructuralDynamics Research corp. of Ohio; and PATRAN by PDA Engineering of CostaMesa, Calif. Typical FEM software comprises modules to create an elementmesh from a plurality of device segments (e.g., to create arepresentation of a simulated device), to analyze a defined problem, andto review results of modified parameters on device design.

Preferred frame configurations were developed that desirably distributemechanical load (e.g., strain or stress) imposed by periodic radialcontraction and expansion. These preferred frame configurationstherefore permit the selection of frame configurations with a lowerprobability of fracture and irritation of the vessel. Preferred framedesigns may provide improved and more uniform strain distribution.Certain critical frame regions showed higher strain during FEA analysis.These included the bends of the proximal and distal hoop members as wellas the points of attachment of bridging members to either hoop member.In general, strain was largely concentrated in radial arcs, flexuralarcs and/or flexural struts. In bend areas where initial stress and/orstrain were high, the geometry of the bend was changed to reduce themaximum stress and/or strain in these areas.

Preferred frame configurations may be discussed with reference tocertain preferred frame configurations comprising two or more undulatinghoop members joined by longitudinal connecting members to form tubularimplantable frames, described herein to illustrate various embodimentsof the invention. Preferred frame geometries allow radial compression ofthe frame (crimping) around a conventional delivery balloon catheter,resulting in a low profile (e.g., 6 F) guiding catheter compatible stentdelivery system. The percentage of axial shortening upon expanding theballoon is preferably minimized, and can be less than 5%.

In a first embodiment, preferred implantable frames include two hoopmembers joined by a plurality of longitudinal connecting members. Forexample, a first implantable frame 12 is provided as shown in FIGS.1A-2B. The first implantable frame 12 includes a proximal undulatinghoop member 100 connected to a distal undulating hoop member 200 by aplurality of longitudinal connecting members 300. Preferably, theundulating hoop members 100, 200 have the same or substantially similarconfigurations. In the first implantable frame 12, the proximalundulating hoop member 100 is longitudinally adjacent to the distalundulating hoop member 200, but is oriented in the opposite longitudinaldirection. Most preferably, the frames assume a radially expandedconfiguration having a pair of longitudinally adjacent radiallycompressible undulating hoop members connected by a plurality ofsubstantially parallel longitudinal connecting members, as shown, forexample, in the first implantable frame 12. The implantable frame canhave a substantially cylindrical exterior surface area defining aplurality of openings therein. The frame openings are preferably definedby at least a portion of the plurality of hoop members, and at least onelongitudinal connecting member.

Certain structural features of the implantable frames may be discussedherein with reference to flat plan schematic views, which are twodimensional representations of an implantable frame obtained bytheoretically bisecting the implantable frame parallel to itslongitudinal axis, “unrolling” the frame and pressing the implantableframe into a flat configuration. FIG. 1A is a flat plan schematic viewof the first implantable frame 12. FIG. 1A shows an unrolled flat planview 10 of the first implantable frame 12. The first implantable frame10 is oriented along a longitudinal axis L.sub.A, having a proximaldirection 2 and distal direction 4.

A flat plan view can be schematically converted into an assembled viewof the implantable frame by “rolling” the two transverse edges out ofthe plane of the flat plan view and joining portions of the transverseedges of the frame to form a three dimensional assembled implantableframe. Reference to the flat plan view 10 is provided to show theconfiguration of the entire implantable frame 12 in a two-dimensionaldrawing, but does not, however, suggest or imply any that firstimplantable frame 12 must be manufactured by any the particular methodof manufacture involving the manipulation of a frame from a flat plan toand assembled configuration. Flat plan views are provided merely toillustrate the entire configuration of a frame in a two-dimensionalmanner, without limiting the manner in which the implantable frames aremanufactured. The flat plan view 10 of FIG. 1A can be converted to an“assembled” radially expanded configuration 20 shown in perspective viewof FIG. 1B by theoretically “rolling” the frame around the longitudinalaxis L.sub.A so as to “connect” portions of the first implantable frame12 between point A and point B at the proximal edge of the implantableframe 12 and point A′ and point B′ at the distal end of the implantableframe 12, respectively. The implantable frame 12 may be manufactured inany suitable manner. Preferably, the implantable frame 12 ismanufactured without providing the frame 12 in the flat plan view 10.Instead, the implantable frame 12 is preferably produced in the“assembled” configuration 20 by laser cutting away portions of a solidtube of self-expanding material in a radially compressed configuration,and permitting the frame to expand to assume the radially expandedconfiguration 20 shown in FIG. 1B. Alternatively, a sheet of suitablematerial can be cut to form a frame in a planar configuration shown inthe flat plan view 10 in FIG. 1A, which can be rolled into the assembledconfiguration of view 20 by joining to itself by any suitable means, asindicated above.

The frame is preferably moveable between a radially compressed state anda radially expanded state by any suitable means within a body vessel,including balloon expansion or self-expansion from a delivery catheterpositioned within a body vessel. The first implantable frame 10 ismoveable from the expanded state 20 shown in FIG. 1B to a radiallycompressed state 30 shown in FIG. 1C. The radially compressedconfiguration 30 is formed by radially compressing the first implantableframe 12 in the assembled configuration 20 in FIG. 1B around thelongitudinal axis L.sub.A.

Referring to FIGS. 1A-2B, the first implantable frame 12 comprises aproximal undulating hoop member 100 connected to a distal undulatinghoop member 200 by an array of longitudinal connecting members 300,including a first longitudinal connecting member 310 and a secondlongitudinal connecting member 320 and a third longitudinal connectingmember 330. The first implantable frame 12 includes a total of eightlongitudinal connecting members 300, with the remaining longitudinalconnecting members designated 312 a, 312 b, 312 c, 312 d and 312 e inFIGS. 1A and 2B. The second longitudinal connecting member 320 iscircumferentially adjacent to the first longitudinal connecting member310 on one side, and longitudinally adjacent to the third longitudinalconnecting member 330 on the opposite side. Each longitudinal connectingmember preferably extends between a first hoop member 100 and a secondhoop member 200. Preferably, the longitudinal connecting members 300 areof substantially the same length and have a substantially constant andsubstantially identical cross section throughout their entire length.Preferably, the longitudinal connecting members are substantiallystraight. In the first implantable frame 12, all eight of thelongitudinal connecting members 300 are oriented substantially parallelto one another, and are substantially parallel to the longitudinal axisof the implantable frame L.sub.A.

FIG. 2A shows a hypothetical cross sectional plane 1000 bisecting theperspective view 20 of the first implantable frame 12 shown in FIG. 1B.FIG. 2B shows the cross sectional view of the first implantable frame 12within the hypothetical cross sectional plane 1000 shown in FIG. 2A,showing the arrangement of longitudinal connecting members 300 aroundthe perimeter of the first implantable frame 12. Preferably, theimplantable frame includes one or more pairs of closely-spacedlongitudinal connecting members. The recitation of “closely-spaced” asused herein to describe pairs of longitudinal connecting members meansthat at least one of the pair of longitudinal connecting members iscircumferentially closer to the other longitudinal connecting memberthan to another adjacent longitudinal connecting member. Referring tothe first implantable frame 12 illustrated in FIGS. 2A-2B, the firstimplantable frame includes four pairs of closely spaced longitudinalconnecting members: 310-320, 330-312 e, 312 c-312 d and 312 a-312 b.Each pair of closely-spaced longitudinal connecting members iscircumferentially closer to the other closely-spaced longitudinalconnecting member than to the other circumferentially adjacentlongitudinal connecting member. The second longitudinal connectingmember 320 is circumferentially adjacent both the first longitudinalconnecting member 310, and the third longitudinal connecting member 330,but is only closely-spaced with respect to the first longitudinalconnecting member 310.

The circumferential distance between longitudinally adjacentlongitudinal connecting members can be expressed as a radial anglesubtended along the perimeter of a cross section of the implantableframe. For example, a first angle δ is subtended between theclosely-spaced circumferentially adjacent longitudinal connectingmembers 320 and 310, as shown in FIG. 2B. The first radial angle δ ismeasured between a first radius 5 a extending from the longitudinal axisL.sub.A to the middle of the first longitudinal connecting member 310,and a second radius 5 b extending from the longitudinal axis L.sub.A tothe middle of the second longitudinal connecting member 320. Preferably,the angle subtended between closely-spaced longitudinal connectingmembers is a function of the total number of longitudinal connectingmembers 300 in the implantable frame. The implantable frame may includea first longitudinal connecting member and a closely-spaced secondlongitudinal connecting member where the angle subtended 6 by ahypothetical arc extending circumferentially between the firstlongitudinal connecting member and the second longitudinal connectingmember is less than (2.pi./n) radians, where n is the number oflongitudinal connecting members connecting the longitudinally adjacenthoop members. The integer (n) is preferably greater than or equal to 2,including 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18,19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, or more. Morepreferably, (n) is 4, 5, 6, 7, 8, 9, 10, 11 or 12. Most preferably, (n)is 4, 6 or 8. For example, the first implantable frame 12 includes eightlongitudinal connecting members (n=8) and the subtended angle 5 is lessthan (2.pi./8) radians (i.e., less than 45.degree.). Each of theclosely-spaced pairs of longitudinal connecting members in the firstimplantable frame 12 have an equal angle subtended between eachlongitudinally-spaced pair that is approximately equal to about (.pi./8)radians (i.e., about 22.5.degree.). Other implantable frame embodimentsprovide implantable frames with two or more pairs of closely-spacedlongitudinal connecting members having different circumferentialdistances between two or more of the closely-spaced pairs oflongitudinal connecting members. For example, an implantable frame mayinclude a first pair of closely-spaced longitudinal connecting memberscircumferentially placed to subtend a first angle less than (2.pi./n)radians, and a second pair of closely-spaced longitudinal connectingmembers circumferentially placed to subtend a second angle less than thefirst angle. Alternatively, an implantable frame may include a firstpair of closely-spaced longitudinal connecting members circumferentiallyplaced to subtend a first angle greater than or equal (2.pi./n) radians,and a second pair of closely-spaced longitudinal connecting memberscircumferentially placed to subtend a second angle less than (2.pi./n)radians.

Preferably, the circumferential distance subtended by the angle δsubtended between the first longitudinal connecting member 310 and thesecond longitudinal connecting member 320 is less than 25% of thelongitudinal length of the longitudinal connecting members 310, 320, andmore preferably about 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18,19, 20, 21, 22, 23, 24 or 25% of the length of the longitudinalconnecting members 310, 320, and most preferably about 10% to about 15%of the length of the longitudinal connecting members 310, 320.

An implantable frame preferably further includes two or more hoopmembers axially aligned around a longitudinal axis of the frame. Thehoop members can have any suitable configuration. The frame preferablyincludes one or more undulating hoop members formed from a plurality ofinterconnected struts and bends oriented along the longitudinal axis ofthe frame. The first implantable frame 12 comprises a first hoop member100 axially aligned with respect to a second hoop member 200 andconnected by the plurality of longitudinal connecting members 300. Eachhoop member 100, 200 is a substantially circular ring comprising anundulating pattern of struts and bends, however hoop members may haveany suitable configuration. The first hoop member 100 and the secondhoop member 200 have the same size and configuration of struts andbends, but implantable frames may include hoop members having differentconfigurations or sizes. The first hoop member 100 and the second hoopmember 200 are substantially equal in radius and are concentricallyaligned in the assembled frame configuration. Preferably, each hoopmember 100, 200 is formed from a plurality of struts of substantiallyequal length and cross-sectional area, as shown in the first implantableframe 12, although implantable frames may include struts of differentlengths or cross sectional areas. Each hoop member 100, 200 can have anysuitable number and combination of struts and bends. For example, aframe can include a first undulating hoop member having a total of (m)struts joined to a total of up to (2 m) longitudinal connecting members,wherein (m) is preferably an integer equal to 2-16, preferably 2-8.Referring to the first implantable frame 12, each hoop member 100, 200is an undulating hoop member formed from four struts joined to oneanother by one or more bends, each hoop member 100, 200 having a totalof eight bends (m=4). The hoop members 100, 200 of the first implantableframe 12 are joined by a total of eight (n=2 m=8) longitudinalconnecting members. Each hoop member typically includes an undulatingpattern of struts and bends extending along the axis of the frame.Preferably, the ratio of bends to struts in an undulating hoop member is1:1 to 3:1, more preferably 2:1 to 3:1, including 1:1.5, 1:2, 1:2.5, 1:3and any other ratio between 1:1 and 1:3. Undulating hoop membersdesirably comprise struts having a substantially equal length withineach undulating hoop member. Alternatively, one or more hoop members canhave a planar rather than undulating geometry, such as a single bentmember forming an annular shape. The plurality of hoop members can havethe same or different configurations, but are preferably concentricallyaligned along the longitudinal axis of the frame. Each of the bends inthe hoop members are preferably connected to a longitudinally adjacenthoop member by at least one longitudinal connecting member.

The hoop members 100, 200 preferably define a circumference enclosing alumen of substantially equal area. Each hoop member 100, 200 desirablyforms a perimeter around a substantially circular or elliptical lumen.FIG. 2B shows a cross sectional view of the first implantable frame 12defining a substantially circular lumen 3 centered on the longitudinalaxis L.sub.A. The first hoop member 100 is longitudinally adjacent tothe second hoop member 200. Longitudinally adjacent hoop members arepreferably oriented in a “peak-to-peak” orientation, and can bepositioned to align longitudinally adjacent struts circumferentiallyparallel to one another along the exterior surface of the frame. Forexample, the first hoop member 100 is oriented in a peak-to-peakorientation with respect to the longitudinally adjacent second hoopmember 200.

The hoop members can further comprise a plurality of lateral supportarms connecting facing pairs of adjacent struts within the hoop memberspositioned at the ends of the frame. A lateral support arm is a portionof a frame extending between portions of a single undulating hoopmember. Each undulating hoop member 200, 300 of the first implantableframe 12 includes two lateral support arms 110 connectingcircumferentially adjacent struts. Each lateral support arm 110preferably comprises a single bend connecting a pair of lateral supportstruts. An implantable frame can comprise any suitable number of lateralsupport arms. Hoop members positioned at the end of a frame preferablycomprise one lateral support arm joining circumferentially adjacentstruts of each hoop member and extending toward the ends of the frame.Preferably, each lateral support arm bridges a single bend in anundulating hoop member.

The support frame can optionally comprise additional structures betweencircumferentially adjacent longitudinal connecting members, such ascircumferential reinforcing members and longitudinal attachment members.Circumferential reinforcing members extend circumferentially betweenlongitudinal connecting members. An implantable frame can comprise anysuitable number of circumferential reinforcing members, longitudinalattachment members, or combination thereof, positioned in any suitableposition and orientation with respect to one another. FIG. 3A shows aside view of a second implantable frame 412 in the radially expandedconfiguration. The second support frame 412 is the same as the firstsupport frame 12 except as described below. The second support frame 412comprises a first circumferential reinforcing member 450 and a secondcircumferential reinforcing member 452 extending in parallel to oneanother between the first longitudinal connecting member 410 and asecond longitudinal connecting member 420.

An implantable frame may also comprise longitudinal attachment memberspositioned between longitudinal connecting members, but attached to onlyon hoop member. Longitudinal attachment members extend longitudinallyfrom a hoop member at a first end, while remaining unattached to theframe at the opposite end. The longitudinal attachment member cancomprise a flexible material suitable for bending into the central lumenof the implantable frame and can include one or more points ofattachment for material. For example, a valve leaflet or graft materialcan be attached to the longitudinal attachment member. FIG. 3C is a sideview 500 of a third implantable frame 512, which is identical to thefirst implantable frame 12 except that the third implantable frame 512further comprises at least one longitudinal attachment member 510attached to the first undulating hoop member 520 and extending between afirst longitudinal connecting member 562 and a second longitudinalconnecting member 564. The longitudinal attachment member 510 ispreferably positioned between a pair of closely spaced longitudinalconnecting members. The first longitudinal connecting member 562 and thesecond longitudinal connecting member 564 are closely-spaced withrespect to each other, have the same length and are orientedsubstantially parallel to the longitudinal axis of the third implantableframe 512. The longitudinal attachment member can be adapted to bendinto the lumen defined by the implantable frame 512, away from thecylindrical outer surface of the implantable frame and serve as anattachment point for material such as a valve leaflet or graft material.

In a second embodiment, implantable frames comprising three or moreundulating hoop members are provided. The hoop members can be the sameor different. Additional undulating hoop members are preferablylongitudinally aligned with a proximal and a distal undulating hoopmember by being centered on a common longitudinal axis in the expandedassembled frame configuration. Teachings related to implantable framescomprising one or more undulating hoop members can be applied by one ofskill in the art to make and use implantable frames with two, three ormore undulating hoop members each preferably joined by one or morelongitudinal connecting members. FIG. 4A is a flat plan view 600 of afourth support frame 612 comprising six axially aligned hoop members620, including hoop members with different configurations. A distal hoopmember 622 and a proximal hoop member 624 each having eight struts andsixteen bends, but oriented in opposite directions. The remaining hoopmembers positioned between the distal hoop member 622 and the proximalhoop member 624 have one of two different configurations, but allindividually comprising eight struts and twenty-four bends. Each hoopmember is connected to the longitudinally adjacent hoop member by anarray of longitudinal connecting members arranged in pairs ofclosely-spaced longitudinal connecting members. For example, the distalhoop member 622 is connected to the longitudinally adjacent hoop memberby eight longitudinal connecting members.

FIG. 4B is a flat plan view 700 of a fifth implantable frame 712comprising five hoop members 720. Each hoop member 720 includes fourstruts and eight bends. Each hoop member is connected to thelongitudinally adjacent hoop member by an array of longitudinalconnecting members arranged in closely-spaced pairs of longitudinalconnecting members. The fifth implantable frame may be formed bylongitudinally connecting a series of modified undulating hoop members100, 200 of the first implantable frame 12 in a coaxial manner to definean elongated frame structure. Both the fourth implantable frame 612 andthe fifth implantable frame 712 are tubular frames having a pattern ofstruts and bends defining a plurality of openings in the exteriorsurface, shown by “rolling” the flat plan views 600 or 700,respectively, to an “assembled” configuration, as described above withrespect to the flat plan view 10.

An implantable frame may also include a single pair of closely-spacedlongitudinal connecting members. For instance, FIG. 5 shows a side view800 of a sixth implantable frame 812 formed by joining a firstundulating hoop member 810 to a second undulating hoop member 820 byfive longitudinal connecting members 830, 832, 834, 835, and 836. Afirst longitudinal connecting member 830 is closely-spaced with respectto a second longitudinal connecting member 832. The remaininglongitudinal connecting members (834, 835, 836) are not closely spaced.

The frame can optionally include a variety of structures ormodifications incorporated in or attached to the frame, to secure theframe within a body vessel upon implantation therein. For example,pointed barbs can be attached to or formed in the frame. In oneembodiment, barbs can be formed in or joined to one or more bends inundulating hoop members. Other structures or structural modificationsfor anchoring the frame in a body vessel are known in the art, andinclude without limitation, forming portions of the frame with barbs,perforations, bioadhesives, roughened surfaces, or heating the frame orportions thereof to bond the frame to the body vessel wall.

The frame can have any size suitable for intralumenal implantation. Thelength of the frame measured along the longitudinal axis is preferablyfrom up to 50 mm, or preferably between 5 mm and 50 mm or higher,including 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21,22, 23, 24, 25, 26, 27, 28, 29, 30, 30, 32, 34, 35, 36, 38, 40, 42, 44,45, 46, 48 and 50 mm, and any increment of 0.25 mm or 0.10 mm incrementthereof. Some preferred embodiments have lengths of 8, 12, 13, 16, 20,23, 24, 25, 28, 32 or 33 mm.

The diameter of the expanded configuration of the implantable frame canbe selected by one skilled in the art given the desired location forimplantation. When in the compressed state for delivery to a desiredlocation within a body lumen, an implantable frame is typically reducedfrom about two to about six times the diameter of the stents when intheir expanded configuration before compression. For example, typicalimplantable frames may have a compressed external diameter of about 1millimeter to about 3 millimeters for delivery and an expanded externaldiameter in a body lumen of about 3 millimeters to about 20 millimeterswhen released from compression in a large body vessel. Some implantableframes used in veins may have a compressed external diameter of about1.00, 1.20, 1.25, 1.40, 1.50, 1.60, 1.75, 1.80, 2.00, 2.20, 2.25, 2.30,2.40, 2.50, 2.60, 2.75, 2.80, 2.90, 3.00 mm or more and an expandedexternal diameter of up to about 20 mm, including between about 1 and 20mm. Some implantable frames, for example for arterial body vessels,preferably have external diameters of 2.00, 2.20, 2.25, 2.30, 2.40,2.50, 2.60, 2.70, 2.75, 2.80, 2.90, 3.00, 3.10, 3.20, 3.25, 3.30, 3.40,3.50, 3.60, 3.70, 3.75, 3.80, 3.90, 4.00, 4.20, 4.25, 4.30, 4.40, 4.50,4.60, 4.70, 4.75, 4.80, 4.90, 5.00 mm, or increments of 0.25, 0.10, 0.05or 0.01 mm between these diameters. Other preferred embodiments, forexample for implantation in veins, have expanded external diameters ofbetween about 3 to about 25 mm, including external diameters of 3, 4, 5,6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24,25 mm, or any increments of 0.25, 0.10, 0.05 or 0.01 mm between thesediameters. In certain preferred embodiments, the implantable frame hasan expanded inner diameter of 1.25, 2.00, 2.50, 2.75, 3.00, or 3.50 mm.

The cross sectional shape of the implantable frame members (includingstruts, bends and longitudinal connecting members) can be selected byone skilled in the art for particular applications, and can have thesame or different shapes throughout the implantable frame or portionsthereof. Suitable cross sectional dimensions of an implantable frame orportion thereof can be selected based on a variety of factors, includingthe intended use of the device, the material and design of the device,and other relevant concerns. The frame forming the undulating hoops,longitudinal connecting struts, or bridging members can have the same ordifferent cross sectional shape(s). In one embodiment, the implantableframe has a square, trapezoidal, circular, triangular or rectangularcross sectional shape. Preferably, the undulating hoop members and thelongitudinal connecting struts both have similar cross sectionaldimensions. Suitable dimensions for each side of a square or rectangularcross section, or for the diameter of a circular cross section, rangefrom 0.001-inch (0.0254 mm) to about 0.100-inch (2.54 mm). Preferably,the longest cross sectional dimension of an implantable frame member isbetween about 0.001-inch (0.0254 mm) and 0.0049-inch (0.1245 mm). In oneembodiment, one side of a rectangular or square cross sectional area (ordiameter of a circular cross sectional area) is between about 0.004-inch(0.102 mm) and about 0.010-inch (0.254 mm). In some embodiments, atleast a portion of the frame has a strut thickness of 0.0022, 0.0025,0.0027, 0.0036, 0.0037, 0.0049, 0.005, 0.0055, 0.006, or 0.009-inch. Forexample, one preferred embodiment has an implantable frame with a widthof 0.2286 mm (0.0090-inch) along the external surface of the implantableframe along the undulating hoop members and the longitudinal connectingmembers. In some embodiments, the implantable frame can comprisebridging members with a width of about 0.0060-inch or 0.0090-inch. Inone preferred embodiment, the implantable frame has a length of 25.00 mmand an external outer diameter of 12.50 mm in the expandedconfiguration, and an outer diameter of 3.0 mm in the compresseddelivery configuration.

Preferred materials for frames include those materials that can providethe desired functional characteristics with respect to mechanical loadbearing, biological compatibility, modulus of elasticity, radio-opacity,or other desired properties. For some embodiments, the materials used toform the implantable frames can comprise a material that exhibitsexcellent corrosion resistance. For some embodiments, the material canbe selected to be sufficiently radiopaque and create minimal artifactsduring magnetic resonance imaging techniques (MRI). In some embodiments,the implantable frame can comprise a metal, a metal alloy, a polymer, orany suitable combination thereof, for example as frame with multiplelayers.

Preferably, the implantable frames are self-expanding stents comprisinga material capable of significant recoverable strain to assume a lowprofile for delivery to a desired location within a body lumen. Afterrelease of the compressed self-expanding stent, it is preferred that theframe be capable of radially expanding back to its original diameter orclose to its original diameter. Accordingly, some embodiments provideframes made from material with a low yield stress (to make the framedeformable at manageable balloon pressures), high elastic modulus (forminimal recoil), and is work hardened through expansion for highstrength. Particularly preferred materials for self-expandingimplantable frames are shape memory alloys that exhibit superelasticbehavior, i.e., are capable of significant distortion without plasticdeformation. Frames manufactured of such materials may be significantlycompressed without permanent plastic deformation, i.e., they arecompressed such that the maximum strain level in the stent is below therecoverable strain limit of the material. Discussions relating to nickeltitanium alloys and other alloys that exhibit behaviors suitable forframes can be found in, e.g., U.S. Pat. No. 5,597,378 (Jervis) and WO95/31945 (Burmeister et al.). A preferred shape memory alloy is Ni—Ti,although any of the other known shape memory alloys may be used as well.Such other alloys include: Au—Cd, Cu—Zn, In—Ti, Cu—Zn—Al, Ti—Nb,Au—Cu—Zn, Cu—Zn—Sn, CuZn—Si, Cu—Al—Ni, Ag—Cd, Cu—Sn, Cu—Zn—Ga, Ni—Al,Fe—Pt, U—Nb, Ti—Pd—Ni, Fe—Mn—Si, and the like. These alloys may also bedoped with small amounts of other elements for various propertymodifications as may be desired and as is known in the art. Nickeltitanium alloys suitable for use in manufacturing implantable frames canbe obtained from, e.g., Memory Corp., Brookfield, Conn. One suitablematerial possessing desirable characteristics for self-expansion isNitinol, a Nickel-Titanium alloy that can recover elastic deformationsof up to 10 percent. This unusually large elastic range is commonlyknown as superelasticity.

In some embodiments, the implantable frames are designed to be expandedby a balloon or some other device (i.e., the frames are notself-expanding), and may be manufactured from an inert, biocompatiblematerial with high corrosion resistance that can be plastically deformedat low-moderate stress levels, such as tantalum. The implantable framescan be deployed by both assisted (mechanical) expansion, i.e. balloonexpansion, and self-expansion means. In embodiments where theimplantable frame is deployed by mechanical (balloon) expansion, theimplantable frame is made from materials that can be plasticallydeformed through the expansion of a mechanical assist device, such as bythe inflation of a catheter based balloon. When the balloon is deflated,the frame can remain substantially in the expanded shape. Otheracceptable materials include stainless steel, titanium ASTM F63-83Grade1, niobium or high carat gold K 19-22. One widely used material forballoon expandable structures is stainless steel, particularly 316Lstainless steel. This material is particularly corrosion resistant witha low carbon content and additions of molybdenum and niobium. Fullyannealed, stainless steel is easily deformable. Alternative materialsfor mechanically expandable structural frames that maintain similarcharacteristics to stainless steel include tantalum, platinum alloys,niobium alloys, and cobalt alloys.

In addition, the frames may be formed from or coated with othermaterials, such as polymers and bioabsorbable polymers may be used forthe implantable frames. In one embodiment, the implantable frame isformed from 316L stainless steel. In another embodiment, the implantableframe is formed from a cobalt chromium alloy. The implantable frames canalso comprise (that is, be formed from or coated with) a variety ofpolymers with limited bioabsorbability, including polyethylene (PE);polypropylene (PP); polyisobutylene; poly(alpha olefin);alkyl(alkyl)acrylates such as poly(n-butyl methacrylate) (PBMA)poly(methyl acrylate) or poly(methyl methacrylate) (PMMA); poly(ethylacrylate); parylenes such as parylene C; ethyl vinyl acetate (EVA);poly(ethylene-co-vinyl acetate) (PEVA), or copolymers or mixturesthereof.

For some embodiments, it is desirable to provide implantable framescomprising bioabsorbable polymers. Bioabsorbable materials absorb intothe body after a period of time. The period of time for the structuralframe to absorb may vary, but is typically sufficient to allow desiredbiological processes such tissue growth to occur at the implantlocation. The implantable frames can comprise one or more bioabsorbablematerials. A wide variety of bioabsorbable materials are known in theart, as well as equivalents thereof, can be used to form implantableframe. Nonlimiting examples of bioabsorbable polymers include polyesterssuch as poly(hydroxyalkanoates), poly(lactic acid) or polylactide (PLA),poly(glycolic acid) or polyglycolide (PGA), poly(caprolactone),poly(valerolactone) and co-polymers thereof; polycarbonates;polyoxaesters such as poly(ethylene oxalate), poly(alkylene oxalates);polyanhydrides; poly(amino acids); polyphosphazenes; phosphorylcholine;phosphatidylcholine; various hydrogels; polydioxanone, poly(DTEcarbonate), and co-polymers or mixtures of two or more polymers. Theimplantable frames can also include various natural polymers such asfibrin, collagens, extracellular matrix (ECM) materials, dextrans,polysaccharides and hyaluronic acid.

The implantable frames or portions thereof can optionally comprisematerial that permits identification of the position or orientation ofthe frame within a body passage. Radiopaque markers are advantageouslypositioned at one or more ends of the implantable frame to aid thephysician in positioning the frame at a site inside a body vessel. Forexample, portions of the implantable frame can include a radiopaquematerial that can be identified by X-rays. The frame can also comprisematerials that are useful with contrast dyes to identify the framewithin a body passage. For example, the first implantable frame 12, asshown in FIG. 1A, comprises a plurality of radiopaque markers 112attached to the bridging members 110. Numerous materials known in theart, and equivalents thereof, can be used in the implantable frames toprovide information about the frame in a body vessel. U.S. Pat. No.6,409,752, issued Jun. 25, 2002 to Boatman et al., incorporated hereinby reference, discloses various radiopaque materials that can be used inor on the implantable frames. Nonlimiting examples of radiopaquematerials include, but are not limited to, high-density metals such asplatinum, iridium, gold, silver, tantalum or their alloys, or radiopaquepolymeric compounds. Preferably, radiopaque materials are highly visibleunder fluoroscopic illumination and are visible even at minimalthickness. In some preferred embodiments, the implantable framescomprise radiopaque material such as gold, platinum, tungsten, oriridium, as well as mixtures and alloys thereof, in an eyelet structureattached to one or more bridging members.

The disclosure of various materials for forming the structural frameshould not be construed as limiting the scope of the invention. One ofordinary skill in the art would understand that other materialspossessing similar characteristics may also be used in the constructionof the implantable frame.

The implantable frames may be fabricated using any suitable method knownin the art. Preferably, the complete frame structure is cut from a solidtube or sheet of material, and thus the frame would be considered amonolithic unit. Laser cutting, water-jet cutting and photochemicaletching are all methods that can be employed to form the structuralframe from sheet and tube stock. Still other methods for fabricating thecomplete frame structure as previously disclosed would be understood byone of skill in the art.

Alternatively, the frame can also be formed from wire using wire formingtechniques, such as coiling, braiding, or knitting. By welding the wireat specific locations a closed-cell structure may be created. Thisallows for continuous production, i.e. the components of the implantableframe may be cut to length from a long wire mesh tube. In addition, animplantable frame is constructed from sheet, wire (round or flat) ortubing. The method of fabrication can be selected by one skilled in theart depending on the raw material used. Techniques for formingimplantable frames are discussed, for example, in Dougal et al., “StentDesign: Implications for Restenosis,” Rev. Cardiovasc Med. 3 (suppl. 5),S16-S22 (2002), which is incorporated herein by reference in itsentirety.

In some embodiments, connections between the strut members and the bendsin an undulating hoop member, as well as the connection between theundulating hoop member and the longitudinal connecting members, may beby welding or other suitable connecting means. Other connection meansinclude the use of a binder, heat, or chemical bond, and/or attachmentby mechanical means, such as pressing, welding or suturing. In addition,portions of the frame may be attached by applying a bonding coating.

An implantable frame can optionally be sterilized using any suitabletechnique known in the art, or equivalents thereto. For example, animplantable frame can be sterilized using ethylene oxide sterilization,as described in AAM/ISO 11135:1994 “Medical Devices—Validation andRoutine Control of Ethylene Oxide Sterilization,” incorporated herein byreference in its entirety. In some embodiments, a sterilized implantableframe satisfies a minimum Sterility Assurance Level (SAL) of about10.sup.−6.

Vascular prostheses such as stent and stent/grafts undergo a number ofdifferent strain conditions in-vivo including: radial strain resultingfrom the applied diastolic and diastolic blood pressure, bending due toheart/limb movement and radial point loading due to limb motion orimpact.

A variety of techniques can be used to measure and control the radialstrains applied to vascular prostheses in bench-top simulators. A firsttechnique involves applying a known volumetric fluid displacement to avascular prosthesis that has been installed in a mock artery of knownradial compliance. The volumetric displacement can be adjusted until theapplied pressure closely simulates diastolic and diastolic conditions.The resulting radial strain can then be calculated as known in the art,for example with a formula that uses the volumetric displacement andmock artery dimensions. A second technique involves measuring the radialstrain of the outside diameter of the mock artery using a lasermicrometer. The internal radial strain can then be determined bymultiplying the outside strain by a ratio that has been calculated usingthe outside and inside diameters and poison ratio of the mock arterymaterial.

The implantable frames can be tested by placing them inside latex tubesfilled with a phosphate buffered saline (PBS) solution and pulsating thetube volume to simulate physiological vessel compliance conditions(typically 3-5%). The tubes deflect radially with the applied pulsatilepressure. The tube-stent assembly acts as a mechanical system, producingstrain levels comparable to the vessel-stent system of the human body. Alaser transducer can be used to measure the tube dilation in real-time;Win test uses the resulting signal to control the dilation within presetlevels. At various intervals during the durability test, the devices canbe removed and examined for mechanical integrity under a scanningelectron microscope or with an endoscope assembly. A list of potentialfailure modes and potential tests that were identified by the MMI/ISOTG150, SC2, WG31 committee in developing their working document forendovascular devices, incorporated herein by reference.

For intravascular applications, the use of x-ray angiography, pressurecatheters, or intravascular ultrasound provides a good means fordetermining the radial dilation and pressures that occur during eachheartbeat or extraneous movement. Combining measured data with finiteelement modeling provides a better understanding of the test parametersthat must be generated.

A variety of other test protocols can also be used. Information providedon the FDA Web site about previously approved devices can be useful indeveloping test protocols. Published papers and articles about appliedloading in relevant publications, for example in the orthopedic andintravascular fields. For example, Conti et al., Biomed Sci Instrum35:339-46 (1999), incorporated herein by reference, discusses testing ofintravascular implantable frames.

Optionally, the support frame can include one or more bioactivematerials. Preferably, the bioactive material is releasably associatedwith the frame, meaning that the bioactive material can be released froma medical device comprising the frame upon implantation. Releasablyassociated bioactive materials can be attached to the medical device inany suitable manner, including incorporation of the bioactive materialwithin the frame material, attachment of the bioactive material to theframe material or incorporation of the bioactive material in one or morecoatings applied to the frame material.

The bioactive material can be selected to treat indications such asthrombosis, coronary artery angioplasty, renal artery angioplasty,carotid artery surgery, renal dialysis fistulae stenosis, or vasculargraft stenosis. The bioactive agent can be selected to perform one ormore desired biological functions. An anti-angiogenic or antineoplasticbioactive such as paclitaxel, sirolimus or a rapamycin analog, or ametalloproteinase inhibitor such as batimastat can be incorporated in orcoated on the frame to mitigate or prevent undesired conditions in thevessel wall, such as restenosis. Many other types of bioactive agentscan be incorporated in or coated on a support frame.

Medical devices comprising an antithrombogenic bioactive material areparticularly preferred for implantation in areas of the body thatcontact blood. An antithrombogenic bioactive material is any bioactivematerial that inhibits or prevents thrombus formation within a bodyvessel. The medical device can comprise any suitable antithrombogenicbioactive material. Types of antithrombotic bioactive materials includeanticoagulants, antiplatelets, and fibrinolytics. Anticoagulants arebioactive materials which act on any of the factors, cofactors,activated factors, or activated cofactors in the biochemical cascade andinhibit the synthesis of fibrin. Antiplatelet bioactive materialsinhibit the adhesion, activation, and aggregation of platelets, whichare key components of thrombi and play an important role in thrombosis.Fibrinolytic bioactive materials enhance the fibrinolytic cascade orotherwise aid is dissolution of a thrombus. Examples of antithromboticsinclude but are not limited to anticoagulants such as thrombin, FactorXa, Factor VIIa and tissue factor inhibitors; antiplatelets such asglycoprotein IIb/IIIa, thromboxane A2, ADP-induced glycoproteinIIb/IIIa, and phosphodiesterase inhibitors; and fibrinolytics such asplasminogen activators, thrombin activatable fibrinolysis inhibitor(TAFT) inhibitors, and other enzymes which cleave fibrin. Furtherexamples of antithrombotic bioactive materials include anticoagulantssuch as heparin, low molecular weight heparin, covalent heparin,synthetic heparin salts, coumadin, bivalirudin (hirulog), hirudin,argatroban, ximelagatran, dabigatran, dabigatran etexilate,D-phenalanyl-L-poly-L-arginyl, chloromethy ketone, dalteparin,enoxaparin, nadroparin, danaparoid, vapiprost, dextran, dipyridamole,omega-3 fatty acids, vitronectin receptor antagonists, DX-9065a,CI-1083, JTV-803, razaxaban, BAY 59-7939, and LY-51,7717; antiplateletssuch as eftibatide, tirofiban, orbofiban, lotrafiban, abciximab,aspirin, ticlopidine, clopidogrel, cilostazol, dipyradimole, nitricoxide sources such as sodium nitroprussiate, nitroglycerin, S-nitrosoand N-nitroso compounds; fibrinolytics such as alfimeprase, alteplase,anistreplase, reteplase, lanoteplase, monteplase, tenecteplase,urokinase, streptokinase, or phospholipid encapsulated microbubbles; andother bioactive materials such as endothelial progenitor cells orendothelial cells.

Bioactive materials for use in bio-compatible coatings include thosesuitable for coating on an implantable medical device. The bioactiveagent can include, for example, one or more of the following:antiproliferative agents (sirolimus, paclitaxel, actinomycin D,cyclosporin), immunomodulating drugs (tacrolimus, dexamedthasone),metalloproteinase inhibitors (such as batimastat), antisclerosing agents(such as collagenases, halofuginone), prohealing drugs (nitric oxidedonors, estradiols), mast cell inhibitors and molecular interventionalbioactive agents such as c-myc antisense compounds, thromboresistantagents, antibiotic agents, anti-tumor agents, antiviral agents,anti-angiogenic agents, angiogenic agents, anti-mitotic agents,anti-inflammatory agents, angiostatin agents, endostatin agents, cellcycle regulating agents, genetic agents, including hormones such asestrogen, their homologs, derivatives, fragments, pharmaceutical saltsand combinations thereof. Other useful bioactive agents include, forexample, viral vectors and growth hormones such as Fibroblast GrowthFactor and Transforming Growth Factor-.beta.

A bioactive material can be one or more pro-healing therapeutic agents,which include materials that provide or promote endothelial cellseeding. For instance, coatings comprise antibodies to CD34 receptors onprogenitor circulating endothelial cells. Nitric oxide, vascularendothelial growth factor, and 17-.beta.-estradiol are other examples ofprohealing therapeutic agents. Another prohealing bioactive agent isvascular endothelial growth factor (VEGF). VEGF is an endothelialcell-specific mitogen, and a cytokine involved in processes essential tothe growth, maintenance and repair of vascular structures. VEGF can becoated on an implantable frame. Local drug delivery of VEGF from amedical device, such as a stent frame, can reduce in-stent restenosis.Other examples of pro-healing therapeutic agents, along with methods forcoating the same on implantable medical devices, are provided inpublished U.S. Patent Application Nos. 2005/0092440 (filed Nov. 8, 2002,by Weinstein); 2005/0191333 (filed Apr. 28, 2005 by Hsu); and2005/0148585 (filed Aug. 26, 2004 by Davies et al.), which areincorporated herein by reference.

Various other bioactive materials can be incorporated on or in theframe, including one or more of the following:antiproliferative/antimitotic agents including natural products such asvinca alkaloids (i.e. vinblastine, vincristine, and vinorelbine),paclitaxel, epidipodophyllotoxins (i.e. etoposide, teniposide),antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin andidarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin(mithramycin) and mitomycin, enzymes (L-asparaginase which systemicallymetabolizes L-asparagine and deprives cells which do not have thecapacity to synthesize their own asparagine); antiplatelet agents suchas (GP) II b/IIIa inhibitors and vitronectin receptor antagonists;antiproliferative/antimitotic alkylating agents such as nitrogenmustards (mechlorethamine, cyclophosphamide and analogs, melphalan,chlorambucil), ethylenimines and methylmelamines (hexamethylmelamine andthiotepa), alkyl sulfonates-busulfan, nirtosoureas (carmustine (BCNU)and analogs, streptozocin), trazenes-dacarbazinine (DTIC);antiproliferative/antimitotic antimetabolites such as folic acid analogs(methotrexate), pyrimidine analogs (fluorouracil, floxuridine, andcytarabine), purine analogs and related inhibitors (mercaptopurine,thioguanine, pentostatin and 2-chlorodeoxyadenosine {cladribine});platinum coordination complexes (cisplatin, carboplatin), procarbazine,hydroxyurea, mitotane, aminoglutethimide; hormones (i.e. estrogen);anticoagulants (heparin, synthetic heparin salts and other inhibitors ofthrombin); fibrinolytic agents (such as tissue plasminogen activator,streptokinase and urokinase), aspirin, dipyridamole, ticlopidine,clopidogrel, abciximab; antimigratory; antisecretory (breveldin);anti-inflammatory: such as adrenocortical steroids (cortisol, cortisone,fludrocortisone, prednisone, prednisolone, 6.alpha.-methylprednisolone,triamcinolone, betamethasone, and dexamethasone), non-steroidal agents(salicylic acid derivatives i.e. aspirin; para-aminophenol derivativesi.e. acetaminophen; indole and indene acetic acids (indomethacin,sulindac, and etodalac), heteroaryl acetic acids (tolmetin, diclofenac,and ketorolac), arylpropionic acids (ibuprofen and derivatives),anthranilic acids (mefenamic acid, and meclofenamic acid), enolic acids(piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone),nabumetone, gold compounds (auranofin, aurothioglucose, gold sodiumthiomalate); immunosuppressives (cyclosporine, tacrolimus (FK-506),sirolimus (rapamycin), tacrolimus, everolimus, azathioprine,mycophenolate mofetil); angiogenic agents: vascular endothelial growthfactor (VEGF), fibroblast growth factor (FGF); angiotensin receptorblockers; nitric oxide and nitric oxide donors; anti-senseoligonucleotides and combinations thereof; cell cycle inhibitors, mTORinhibitors, and growth factor receptor signal transduction kinaseinhibitors; retenoids; cyclin/CDK inhibitors; endothelial progenitorcells (EPC); angiopeptin; pimecrolimus; angiopeptin; HMG co-enzymereductase inhibitors (statins); metalloproteinase inhibitors(batimastat) and protease inhibitors. Other examples of bioactivecoating compounds include antibodies, such as EPC cell marker targets,CD34, CD133, and AC 133/CD133; Liposomal Biphosphate Compounds (BPs),Chlodronate, Alendronate, Oxygen Free Radical scavengers such asTempamine and PEA/NO preserver compounds, and an inhibitor of matrixmetalloproteinases, MMPI, such as Batimastat. Still other bioactiveagents that can be incorporated in or coated on a frame include a PPARagonist and RXR agonists, as disclosed in published U.S. PatentApplication US2004/0073297 to Rohde et al., published on Apr. 15, 2004and incorporated in its entirety herein by reference.

The device can be coated with polysaccharides, for example as disclosedin published U.S. Patent Application US2004/091605 to Bayer et al.,published on May 13, 2004 and incorporated herein by reference in itsentirety. In one embodiment, the frame comprises a polysaccharide layerwhich has improved adhesion capacity on the substrate surface of theframe. For example, the coated frame can comprise the covalent bondingof a non-crosslinked hyaluronic acid to a substrate surface of the framewith the formation of hyaluronic acid layer and crosslinking of thehyaluronic acid layer.

The bioactive materials can be attached to the medical device in anysuitable manner. For example, a bioactive can be attached to the surfaceof the medical device, or be positioned within the frame in pores. Oneor more bioactives can be coated on or incorporated within a frame. Inone embodiment, a frame can be configured to absorb a solution of abioactive material. For instance, a frame with absorbent properties canbe selected, or a portion of a medical device can be coated with across-linked polymer hydrogel material to retain a bioactive materialfor elution within a body vessel. A bioactive can be incorporated bysoaking the absorbent portion of the medical device in a solution of thebioactive material and allowing the absorption of the bioactivesolution. Subsequently, the solvent can be evaporated to leave thebioactive within the medical device.

In another embodiment, a frame can also be coated with or formed from abiodegradable polymers, as well as copolymers of degradable polymers. Abioactive material can be mixed with or copolymerized with thebioabsorbable polymer. Alternatively, the bioactive material or amixture of bioactive material and biostable or bioabsorbable polymer canbe coated with a second layer comprising a bioabsorbable polymer. Uponimplantation, absorption of the bioabsorbable polymer releases thebioactive. Bioabsorbable polymers can be formed by copolymerization ofcompatible monomers or by linking or copolymerization of functionalizedchains with other functionalized chains or with monomers. Examplesinclude crosslinked phosphorylcholine-vinylalkylether copolymer andPC-Batimastat copolymers. In one embodiment, the frame is coated with acoating of between about 1.mu.m and 50.mu.m, or preferably between3.mu.m and 30.mu.m, although any suitable thickness can be selected. Thecoating can comprise a bioactive material layer contacting a separatelayer comprising a carrier, a bioactive material mixed with one or morecarriers, or any combination thereof. The carrier can be biologically orchemically passive or active, but is preferably selected and configuredto provide a desired rate of release of the bioactive material. In oneembodiment, the carrier is a bioabsorbable material, and one preferredcarrier is poly-L-lactic acid. U.S. patent application Ser. No.10/639,225, filed Aug. 11, 2003 and published as US2004/0034409A1 onFeb. 19, 2004, describes methods of coating a bioabsorbable metalsupport frame with bioabsorbable materials such as poly-L-lactic acidthat are incorporated herein by reference.

Implantable frames or prostheses comprising the implantable frame can bedelivered into a body lumen using a system which includes a catheter. Insome embodiments, implantable frames can be intralumenally deliveredinside the body by a catheter that supports the implantable frame in acompacted form as it is transported to the desired site, for examplewithin a body vessel. Upon reaching the site, the implantable frame canbe expanded and securably placed within the body vessel, for example bysecurably engaging the walls of the body vessel lumen. The expansionmechanism may involve forcing the stent to expand radially outward, forexample, by inflation of a balloon formed in the distal portion of thecatheter, to inelastically deform the stent and fix it at apredetermined expanded position in contact with the lumen wall. Theexpansion balloon can then be deflated and the catheter removed. Inanother technique, the implantable frame is formed of an elasticmaterial that will self-expand after being compacted. Duringintroduction into the body, the implantable frame is restrained in thecompacted condition. When the stent has been delivered to the desiredsite for implantation, the restraint is removed, allowing theimplantable frame to self-expand by its own internal elastic restoringforce. Once the implantable frame is located at the constricted portionof the lumen, the sheath is removed to expose the stent, which isexpanded so it contacts the lumen wall. The catheter is subsequentlyremoved from the body by pulling it in the proximal direction, throughthe larger lumen diameter created by the expanded prosthesis, which isleft in the body.

In some embodiments, the implantable frames impart radially outwarddirected force during deployment, whether self-expanding orradially-expandable. The radially outward directed force can serve tohold the body lumen open against a force directed radially inward, aswell as preventing restriction of the passageway through the lumen byintimal flaps or dissections generated by, such as prior balloonangioplasty. Another function of the radially outward directed force canalso fix the position of the stent within the body lumen by intimatecontact between the stent and the walls of the lumen. Preferably, theoutwardly directed forces does not traumatize the lumen walls.

The implantable frames may be delivered, for example, on their own or aspart of an implantable prosthetic valve. FIG. 6 illustrates a deliverysystem 900. The delivery system 900 includes a catheter 910 having adistal end 914. A balloon 920 is positioned on the distal end 914 of thecatheter 910. A connector assembly 930 is disposed at the proximal end935 of the catheter 910 and is adapted to facilitate expansion of theballoon 920 as is known in the art. The connector assembly 930 providesaccess to an interior lumen of the catheter 910 to provide access to theballoon 920, and possibly a guidewire (not illustrated) or otherconventional component. A balloon expandable implantable frame 950 isdisposed on the distal end 914 of the catheter 910. The implantableframe 950 surrounds the balloon 620 and is initially, prior to placementin a body vessel, in its unexpanded state. This positioning allows theballoon 920, upon inflation, to expand the implantable frame 950 intoits expanded state. The implantable frame 950 can be configured toproviding artificial support to a body vessel or can form part of avalve or stent graft. The implantable frame 950 can be selected from thegroup consisting of: the first implantable frame 12, the secondimplantable frame 412, the third implantable frame 512, the fourthimplantable frame 612, the fifth implantable frame 712 and the sixthimplantable frame 812, as described above.

Delivery of the implantable frame 950 can be performed by inserting thedistal end 914 of the catheter 910 into a body vessel and navigating thedistal end 914, and the surrounding implantable frame 950, to a point ina vessel in need of artificial support. The catheter 910 can be placedover a guidewire (not illustrated) to facilitate navigation. Once theimplantable frame 950 is at the point of treatment, the balloon 920 canbe inflated in the conventional manner. Inflation of the balloon 920forces the implantable frame 950 to expand. During expansion, in whichthe implantable frame 950 changes from its compressed state to itsexpanded state, circumferentially adjacent longitudinal connectingmembers can deviate from the axially-displaced configuration associatedwith the unexpanded state of the implantable frame 950, becomingsubstantially aligned in the axial direction. Following expansion, theballoon 920 can be deflated. The catheter 910 can then be withdrawn fromthe vessel, leaving the implantable frame 950 in its expanded state atthe point of treatment within the body vessel.

An appropriately sized delivery catheter can be selected by one skilledin the art for a given application. For example, some embodiments can bedelivered using a delivery catheter selected from one or more deliverycatheter sizes from the group consisting of: 1, 2, 3, 4, 5, 6, 7, 8, 9,10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27,28, 29 and 30 french (F) delivery catheters, or increments of 0.1 Ftherebetween. In some embodiments, a delivery catheter sized between 1and 25 F, or preferably between about 1.5 F and 5 F can be used,preferably a 1.8 F (0.60 mm), 2.0 F (0.66 mm), 2.3 F (0.75 mm), 2.6 F(0.85 mm), 2.7 F (0.9 mm), 2.9 F (0.95 mm), or 3.3 (1.10 mm) deliverycatheters. Kits comprising implantable frames are also provided. In oneembodiment, a kit comprises an implantable frame and a deliverycatheter.

The implantable frames can be placed in any medically appropriatelocation for a given application. For example, in some embodiments, theimplantable frame can serve as part of a venous valve prosthetic and beimplanted in the femoral vein, including at the proximal (groin), mid(mid section) or distal (adjacent to the knee) portions of the vein.Implantable frames can be deployed at various locations and lumens inthe body, such as, for example, coronary, vascular, nonvascular andperipheral vessels, ducts, and the like, including but not limited tocardiac valves, venous valves, valves in the esophagus and at thestomach, valves in the ureter and/or the vesica, valves in the biliarypassages, valves in the lymphatic system and valves in the intestines.In one embodiment, a valve leaflet is attached to the frame to providean implantable valve prosthesis that can be implanted within a vein, forinstance, near an incompetent venous valve to treat venous valveinsufficiency. Methods of treatment preferably include the steps ofloading an implantable frame, or a device comprising an implantableframe, in a compressed state into a delivery catheter, inserting thedelivery catheter into a body vessel, translating the delivery catheterto a desired location, deploying the device comprising the implantableframe by securably placing the device in an expanded state at thedesired location, and withdrawing the delivery catheter from the bodyvessel.

The foregoing disclosure includes the best mode devised by the inventorfor practicing the invention. It is apparent, however, that severalvariations in intralumenal graft assemblies in accordance with thepresent invention may be conceivable by one skilled in the art. Inasmuchas the foregoing disclosure is intended to enable one skilled in thepertinent art to practice the instant invention, it should not beconstrued to be limited thereby, but should be construed to include suchaforementioned variations.

1. An implantable frame defining a lumen extending between a proximalend and a distal end along a longitudinal axis, the implantable framehaving a substantially cylindrical exterior surface area with aplurality of openings, the implantable frame moveable between acompressed state and an expanded state, the implantable framecomprising: a first hoop member and a second hoop member axiallyadjacent to the first hoop member, each of the first and second hoopmembers comprising a plurality of interconnected struts and bendsarranged in an undulating shape; the first hoop member comprising afirst bend having a first apex and connecting first and secondcircumferentially adjacent struts; first and second longitudinalconnecting members joining the first hoop member to the second hoopmember, the first and second longitudinal connecting members extendingacross an entire space separating the first and second hoop members;wherein the first longitudinal connecting member has a first endattached to the first apex; and wherein the second longitudinalconnecting member has a second end attached to the first apex.
 2. Theimplantable frame of claim 1, wherein the second hoop member comprises asecond bend connecting third and fourth circumferentially adjacentstruts; wherein the first longitudinal connecting member has a third endattached to the second bend; and wherein the second longitudinalconnecting member has a fourth end attached to the second bend.
 3. Theimplantable frame of claim 1, wherein the first and second longitudinalconnecting members are disposed parallel to each other.
 4. Theimplantable frame of claim 1, wherein each of the first and second hoopmembers has a substantially equal radius and the first and second hoopmembers are concentrically aligned along the longitudinal axis.
 5. Theimplantable frame of claim 1, wherein the implantable frame comprises2-16 longitudinal connecting members; and wherein each longitudinalconnecting member of the 2-16 longitudinal connecting members extendsacross the entire space separating the first and second hoop members. 6.The implantable frame of claim 1, wherein the implantable frame isself-expandable.
 7. The implantable frame of claim 6, wherein theimplantable frame comprises a shape memory alloy.
 8. The implantableframe of claim 7, wherein the shape memory alloy comprises a nickeltitanium alloy.
 9. The implantable frame of claim 7, wherein the shapememory alloy comprises a member of the group consisting of Au—Cd, Cu—Zn,In—Ti, Cu—Zn—Al, Ti—Nb, Au—Cu—Zn, Cu—Zn—Sn, CuZn—Si, Cu—Al—Ni, Ag—Cd,Cu—Sn, Cu—Zn—Ga, Ni—Al, Fe—Pt, U—Nb, Ti—Pd—Ni, and Fe—Mn—Si alloys. 10.The implantable frame of claim 1, wherein the implantable frame requiresmechanical expansion to move from the compressed state to the expandedstate.
 11. The implantable frame of claim 10, wherein the implantableframe comprises a member selected from the group consisting of stainlesssteel, tantalum, platinum alloys, niobium alloys, and cobalt alloys. 12.The implantable frame of claim 10, wherein the implantable framecomprises a cobalt chromium alloy.
 13. The implantable frame of claim 1,wherein the implantable frame comprises a polymer.
 14. The implantableframe of claim 13, wherein the polymer comprises polyethylene (PE);polypropylene (PP); polyisobutylene; poly(alpha olefin); alkyl(alkyl)acrylates; poly(ethyl acrylate); parylene; ethyl vinyl acetate(EVA); poly(ethylene-co-vinyl acetate) (PEVA); or copolymers or mixturesthereof.
 15. The implantable frame of claim 1, wherein the implantableframe includes a bioactive agent.
 16. The implantable frame of claim 15,wherein the bioactive agent comprises an anti-angiogenic orantineoplastic bioactive.
 17. The implantable frame of claim 16, whereinthe bioactive agent comprises one or more of paclitaxel, sirolimus, arapamycin analog, and a metalloproteinase inhibitor.
 18. The implantableframe of claim 15, wherein the bioactive agent comprises anantithrombogenic bioactive.
 19. The implantable frame of claim 1,wherein the first and second longitudinal connecting members arepositioned such that an angle less than (2n/n) radians is subtended by ahypothetical arc extending circumferentially along the exterior surfacearea of the implantable frame between a first radius extending from thelongitudinal axis to the first longitudinal connecting member and asecond radius extending from the longitudinal axis to the secondlongitudinal connecting member, where (n) is an integer equal to 2 orgreater.
 20. An implantable frame defining a lumen extending between aproximal end and a distal end along a longitudinal axis, the implantableframe having a substantially cylindrical exterior surface area with aplurality of openings, the implantable frame moveable between acompressed state and an expanded state, the implantable framecomprising: a first hoop member and a second hoop member axiallyadjacent to the first hoop member, each of the first and second hoopmembers comprising a plurality of interconnected struts and bendsarranged in an undulating shape; the first hoop member comprising afirst bend having a first apex and connecting first and secondcircumferentially adjacent struts; the second hoop member comprising asecond bend connecting third and fourth circumferentially adjacentstruts; and first and second longitudinal connecting members joining thefirst hoop member to the second hoop member, the first and secondlongitudinal connecting members extending across an entire spaceseparating the first and second hoop members; wherein the firstlongitudinal connecting member has a first end attached to the firstapex and a second end attached to the second bend; wherein the secondlongitudinal connecting member has a third end attached to the firstapex and a fourth end attached to the second bend; and wherein the firstand second longitudinal connecting members are disposed parallel to eachother.
 21. An implantable frame defining a lumen extending between aproximal end and a distal end along a longitudinal axis, the implantableframe having a substantially cylindrical exterior surface area with aplurality of openings, the implantable frame moveable between acompressed state and an expanded state, the implantable framecomprising: a first hoop member and a second hoop member axiallyadjacent to the first hoop member, each of the first and second hoopmembers comprising a plurality of interconnected struts and bendsarranged in an undulating shape; and a plurality of longitudinalconnecting members, each longitudinal connecting member of the pluralityof longitudinal connecting members extending across the entire spaceseparating the first and second hoop members and having a first endattached to a bend of the first hoop member and a second end attached toa bend of the second hoop member; wherein a first bend of the first hoopmember is attached to each longitudinal connecting member of a pair oflongitudinal connecting members of the plurality of longitudinalconnecting members; and wherein a second bend of the second hoop memberis attached to each longitudinal connecting member of the pair oflongitudinal connecting members.